Mark Neal

Background

About Mark Neal

Successful at establishing, implementing and integrating quality management systems for design control, design change, quality systems, CAPA, complaint handling, trend analysis, field actions, manufacturing and service/support. Extensive experience in product development and manufacturing quality engineering for complex electro-mechanical, software-driven embedded systems, associated disposables and applications software in high reliability and human safety critical products from concept to development and distribution. Broad experience in FDA, Competent Authority and ISO Registrar/Notified Body interface including FDA inspections, ISO audits, multiple Warning Letter clearance and product regulatory submissions strategy. Skilled at improving product and process quality through continuous improvement using Six Sigma techniques. Experience in Class I, Class II and Class medical devices, 510(k) and PMA submissions, and with clinical trial requirements. Proven leader in attracting talent, building organizations, and developing employees. • Quality and Regulatory Compliance Strategy • FDA Enforcement Action Turnaround, Remediation and Resolution • Engineering, Quality and Regulatory Technical Proficiency • Continuous Improvement, Lean and Six Sigma Implementation • Multi- Facility and Multi-Geographic Team Leadership • Organizational Design, Enhancement and Sustaining • Coaching, Mentoring and Developing Employees